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Re: BioBS2012 post# 201596

Tuesday, 01/06/2015 7:06:38 PM

Tuesday, January 06, 2015 7:06:38 PM

Post# of 345746

While SK et. al., certainly know the amount of "extra" BAVI they are manufacturing/shipping, it still would not give them an indication of how BAVI is performing with respect to the placebo arm - because they are blinded to that information.


Bio - Good comment. I agree that the placebo arm could have surprises, so right now this manufacuting/dosing information is only insightful for SK in relation to historical norms.

But after the first look-in, which Chris Keenan told me is likely to happen in Q2 of this calendar year, SK will know how many total events/deaths have occurred in both arms and he will be able to compare that to his estimate of the number of patients in the Bavi arm who have not yet progressed.

We know for sure that none of those extra Bavi doses go to the placebo patients, so its not hard to estimate how many Bavi patients still have not progressed, i.e. are alive. Once SK knows the total number of deaths and the number of Bavi patients who are certainly still alive, he can get a pretty good idea of how the Bavi patients are doing relative to the placebo patients.

So I agree with you that, due to possible surprises in the placebo arm, this aggregate dosing information doesn't really become meaningful until the first look-in.


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